|Número de publicación||US7493901 B2|
|Tipo de publicación||Concesión|
|Número de solicitud||US 11/411,633|
|Fecha de publicación||24 Feb 2009|
|Fecha de presentación||26 Abr 2006|
|Fecha de prioridad||6 Oct 1998|
|También publicado como||CA2346248A1, CA2346248C, CA2650214A1, CA2650214C, CA2650215A1, CA2650215C, CA2650217A1, CA2650217C, DE69927167D1, DE69927167T2, DE99947765T1, EP1119386A2, EP1119386B1, EP1600192A2, EP1600192A3, EP1609497A2, EP1609497A3, EP1839696A2, EP1839696A3, US7156100, US7506648, US20050274383, US20060254596, US20090007920, WO2000020062A2, WO2000020062A3|
|Número de publicación||11411633, 411633, US 7493901 B2, US 7493901B2, US-B2-7493901, US7493901 B2, US7493901B2|
|Inventores||Archibald I. J. Brain|
|Cesionario original||The Laryngeal Mask Company Ltd.|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citas de patentes (103), Otras citas (51), Citada por (7), Clasificaciones (10), Eventos legales (3)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This application is a continuation application of U.S. patent application Ser. No. 09/412,954, filed Oct. 5, 1999, and issued Jan. 2, 2007 as U.S. Pat. No. 7,156,100.
This invention relates to laryngeal mask airway devices (LMA-devices) which are artificial airway devices permitting spontaneous or artificial ventilation of the lungs of a patient.
LMA-devices are described in UK Patents Nos. 2,111,394 and 2,205,499. Such devices have become accepted items of equipment for rapidly and reliably establishing an unobstructed airway in a patient in emergency situations and in the administration of anaesthetic gases, and have found use in most countries of the world.
The insertion of such a LMA-device into the throat of the patient is, in the great majority of cases an entirely straightforward procedure which can be carried out successfully following readily understandable training.
Circumstances do, however, occasionally arise during insertion leading to undesirable positioning of the device and/or undesirable forces being applied to the device and/or to the patient. One of the most common of such circumstances is that the leading end of the device, i.e., the distal end of the fully deflated inflatable cuff formation, becomes folded over on itself presenting the more rigid distal end of the mask to catch the inside the throat and subject the patient to undesirable forces. Alternatively, or additionally, the folded over distal end of the cuff will obstruct correct and full inflation of the cuff thereby obstructing the creation of a full seal around the patient's laryngeal inlet and hence obstructing formation of a full enclosed airway to the patient's lungs. This, in turn, may result in anesthetic gases passing unnecessarily into the patient's oesophagus and in any matter regurgitated through the oesophagus entering the larynx and soiling the patient's trachea and lungs.
The present invention seeks to eliminate the disadvantages associated with such undesirable insertion by minimizing the risk of the deflated cuff formation becoming folding over on itself during the insertion procedure. This is achieved by incorporating into the cuff at its distal end a reinforcing rib which serves to stiffen the leading end of the LMA-device during the course of the procedure for its insertion.
In accordance with the invention, there is provided a laryngeal mask airway device comprising a flexible airway tube and a mask attached to one end of the airway tube, the mask having a generally elliptical periphery provided with an inflatable cuff which surrounds the hollow interior of the mask into which the airway tube opens, the device including a reinforcing rib incorporated into the distal end of the inflatable cuff.
In a preferred aspect, the mask structure or backplate which is of a more rigid material than that of the soft and inflatable cuff formation has its back extended to the distal end of the cuff, in order to form the reinforcing rib.
The LMA-device of the invention incorporating such a reinforcing rib has a number of advantages over and above that for which it was specifically devised. Thus, not only does the reinforcing rib largely eliminate the likelihood of the distal end of the deflated cuff formation folding over on itself during insertion of the LMA-device into the patient's throat, but also the cuff is easier to deflate preferably since the reinforcing rib will urge the deflating cuff into the desired orientation. Since the cuff in its deflated state may adopt an upturned or down turned orientation, the reinforcing rib will urge the deflated cuff into the down turned position desirable for insertion into the patient. Further, in addition to the rib being stiffer than the deflated cuff, it will preferably also be more compliant than the material of the bowl of the mask and the stiffness gradient formed by the rib and the mask will assist in the insertion of the device and substantially reduce the likelihood of any hard or angular edges of the bowl of the mask being presented which may subject the patient's throat to undesirable forces. Additionally, the rib will substantially reduce the promontory previously formed by the distal end of the mask structure, rendering the LMA-device substantially self-inserting when it is properly deflated.
As shown in
In accordance with a preferred aspect of the invention, an indentation is provided on the airway tube or backplate at the intended location of finger contact to assist in locating and stabilizing the finger and to reduce the possibility of finger slippage. The indentation is situation on the surface of the airway tube adjacent its junction with the tube-joint, or on the tube-joint itself, and beneath the cuff formation surrounding the backplate. The airway tube usually has a thicker wall at this point, i.e., near the distal end of the airway tube, to form a smooth joint with the tube-joint, and the extra thickness enables the indentation to be accommodated without weakening the airway tube at this location. The tube-joint may also have a thicker wall at this point. Indeed, the indentation serves the additional useful purpose of improving the flexibility of the airway tube or tube-joint at this point. The indentation serves not only to prevent sideways slippage of the finger from the airway tube or tube-joint, but also to minimize the possibility of forward slippage and undesirable contact between the finger and the inflatable cuff, for example by the fingernail.
An additional difficulty which may occur during attempts to insert the LMA-device is that the patient's epiglottis (which protects the entrance to the glottis or larynx) may be pushed downwards or anteriorly as the LMA-device is inserted fully into the throat. Indeed, this occurs in about 40% of cases and can sometimes obstruct breathing. A conventional LMA-device has the interior of the mask which in use surrounds the glottis, communicating with the interior of the airway tube through an aperture which is traversed by two bars, known as mask aperture bars (MABs). The MABs function as a ramp up which the epiglottis slides as the mask is inserted and are intended to hold the epiglottis away from the mask floor when the LMA-device is in its correct operating location. Additionally, the MABs serve to prevent the epiglottis from obstructing the narrow entrance of the airway tube. Generally, the MABs successfully perform this function but occasionally obstruction may occur if the epiglottis is down folded, e.g., anteriorly, or if the mask is not sufficiently advanced into place.
In accordance with a preferred aspect of the invention, the aperture by which the interior of the airway tube opens into the mask is elongated and the MABs are extended to traverse the length of that aperture. By elongating the aperture to half the bowl of the mask, the range of positions of the LMA-device compatible with a clear airway is greatly increased and the angle of ramp up which the epiglottis must slide is reduced, both of which make the epiglottis less likely to be down-folded during insertion of the LMA-device.
In the drawings:
Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.
As used herein, the anatomical terms “anterior” and “posterior”, with respect to the human body, refer to locations nearer to the front of and to the back of the body, respectively, relative to other locations. The term “anterior-posterior (A-P)” refers to a direction, orientation or the like pointing either anteriorly or posteriorly. The anatomical terms “proximal” and “distal”, with respect to applying an instrument to the human body, refer to locations nearer to the operator and to the inside of the body, respectively. Alternatively, “distal”, as opposed to “proximal”, means further away from a given point; in this case, “distal” is used to refer to positions on the LMA-device 20 or in the body relative to the extreme outer or connector end of the LMA-device. “Proximal” is the opposite of “distal”. The term “lateral” refers to a location to the right or left sides of the body, relative to other locations. Alternatively, “lateral” means to one or other side of the mid-line, with respect to the major axis of the body, or to a device lying in the body's major axis. The term “bilateral” refers to locations both to the left and right of the body, relative to the sagittal plane. The term “sagittal” or “sagittally” refers to a vertical longitudinal plane through the center or midline of the body that divides a bilaterally symmetrical body into right and left halves. The sagittal plane is the plane passing antero-posteriorly through the middle of the body in its major axis. The term “medial” means nearer to the mid-line.
A laryngeal-mask airway device (LMA-device) of the present invention, is designated generally by the reference numeral 20 in
As further shown in
An externally accessible cuff-tube 62 and cuff-port 65 on the main-cuff 55 are the means of supplying air to the main-cuff and of extracting air from (and therefore collapsing) the main-cuff for purposes of insertion in or removal from the patient. The check-valve 67 is disposed in the cuff-tube 62 for holding a given inflation or holding a given deflation of the main-cuff 55.
In the installed position of
The major plane 82 is a plane containing the major axis 85 of the main-cuff 55 extending between proximal and distal regions 57, 60. The major plane 82 is disposed between, and parallel to, the anterior and posterior surfaces of the main-cuff 55. Additionally, the major plane 82 is equidistant from the anterior and posterior surfaces of the main-cuff 55.
More specifically, and with particular reference to
As used herein, the term “welding” describes the bonding together of two components having the same or similar chemical compositions, either by adhesive having the same or similar chemical composition as the components, or by high pressure or temperature fusion, or a combination of any of them.
The back-cushion 77, or auxiliary rear cushion, overlies the posterior surface of the backplate 52, as shown in
Inflation-air supply to the back-cushion 77 may be via one or more ports in the main-cuff 55 which provide communication between the interiors of the main-cuff and back-cushion so that both are inflated and deflated together. Alternatively, inflation-air supply to the back-cushion 77 may be via a separate inflating means, such as an inflation tube (not shown), similar to cuff-tube 62, may be provided for the back-cushion so that the back-cushion 77 and main-cuff 55 are separately and independently inflatable and deflatable.
If the main-cuff 55 and back-cushion 77 are inflated and deflated together, communication between the main-cuff and back-cushion may be facilitated by a separate tube (not shown), preferably with multiple perforations along its length, contained within the main-cuff in communication with the cuff-port 65 such that each perforation communicates with a port between the interiors of the main-cuff and back-cushion 77. Such a separate tube preserves a flowpath between the cuff-port 65 and back-cushion 77 if the main-cuff 55 is completely collapsed from deflation, thereby providing for further deflation of the back-cushion 77 via the cuff-port 65. Alternatively, a channel (not shown) may be formed on the inner surface of the main-cuff 55 between the opening of the cuff-tube 62 into the main-cuff and at least one of the one or more ports between the interiors of the main-cuff and back-cushion 77. Such a channel preserves a flowpath between the cuff-tube 62 and back-cushion 77 if the main-cuff 55 is completely collapsed from deflation.
The backplate 52 has a one-piece, integral spoon-shape including a bowl 90 and an external tube-joint 92 oriented proximally relative to the bowl, as shown in
The proximal portion of the bowl 90 sandwiched between the pharyngeal- and laryngeal-sides 95, 97 abuts the posterior surface of the seam 87, as shown in
When the backplate 52 is attached to the main-cuff 55, the distal rib 105 pierces the proximal surface of the distal region 60. The edges of the main-cuff 55 in the distal region 60 surrounding the distal rib 105 are hermetically sealed to it such that the enclosure of the main-cuff is defined in part by the distal rib. The distal rib 105 extends through the interior of the main-cuff 55 to the distal surface of the distal region 60.
The bowl 90 has a longitudinally elongated airway aperture 107 into which opens a backplate passage 110 extending through the tube-joint 92. The airway aperture 107 has a major axis 111 which is contained in the sagittal plane 112.
Two mask aperture bars (MABs) 115, 117 extend longitudinally and anteriorly of the airway aperture 107, as shown in
The MABs 115, 117 may be defined by a portion of a continuous layer of elastomer, integral with the main-cuff 55, which overlies the laryngeal-side 97. The elastomer layer has an opening the periphery of which is outward of the airway aperture 107. The opening is longitudinally traversed by the MABs 115, 117.
The distal ends 125, 127 of the MABs 115, 117 are joined to the bowl 90 generally near the longitudinal mid-point of the laryngeal-side 97, or distally of it. This results in each MAB 115, 117 forming an angle 118 with the bowl plane 106 which is less than the corresponding angle between the MAB P1 of a prior LMA-device, as shown in
The elongate tube-joint 92 is formed on the pharyngeal-side 95 and extends posteriorly and proximally relative to the bowl 90. The tube-joint 92 has a proximal end 130 from which the backplate passage 110 extends to the airway aperture 107 in the laryngeal-side 97. The backplate passage 110 has a longitudinal central axis 132 contained in the sagittal plane 112. At the proximal end 130, the backplate passage 110 has an elliptical cross section with a major axis 135 oriented in perpendicular relation to the sagittal plane 112. The major axis 135 is therefore transverse to the major axis 111 of the airway aperture 107. This differing orientation of the major axes 111, 132 of the backplate passage 110 is accomplished by a smooth transition in the cross-sectional shape of the backplate passage along its length.
The tube-joint 92, and the central axis 132 of the backplate passage 110 are inclined posteriorly in the sagittal plane 112 relative to a plane containing the periphery of the bowl 90. In the embodiment shown in
The anterior surface of the tube-joint 92 has an indentation 140, as shown in
The backplate 52, main-cuff 55 and back-cushion 77 of LMA-devices 20 are generally manufactured by molding techniques from suitably soft and compliant rubber materials. The backplate 52 and inflatable main-cuff 55 may be formed as a one piece molding by molds and molding techniques such as are described, for example, in U.S. Pat. No. 5,305,743, the contents of which are hereby incorporated herein. The backplate 52 is formed to have a greater thickness than the walls of the main-cuff 55 to provide the LMA-device 20 with a degree of rigidity while still allowing it to have an overall soft and flexible nature. The main-cuff 55 has a thin-walled construction and the reinforcing distal rib 105 has an intermediate thickness and compliancy.
As shown in
Insertion of the LMA-device 20 into the patient's throat 22 is illustrated in
As shown in
In the embodiment shown in
The acute angle 118 between the MABs 115, 117 and the bowl plane 106 results in the MABs presenting a substantially less gradient to the patient's epiglottis 40 than the MABs P1 of a prior-LMA, as shown in
When the main-cuff 55 and backplate 52 are installed in the pharynx 30 such that main-cuff is sealed against the tissues surrounding the patient's laryngeal inlet 45, the reduced angle 137 between the tube-joint axis 136 and bowl plane 106, relative to the corresponding force resulting from tube-joint P2, reduces the force exerted by the tube-joint 92 and airway tube 47 against the posterior surface of the throat 22. Any force against the tissues of the throat 22 should normally be limited.
The reduction in the force exerted by the tube-joint 92 and airway tube 47 against the posterior surface of the throat 22 may result in a reduction in the reaction force of the main-cuff 55 against the tissues surrounding the patient's laryngeal inlet 45 which, in turn, may reduce the tightness of the seal between the main-cuff and tissues. Any such reduction in the seal is compensated for the inflatable back-cushion 77 which gently urges the backplate 52 and main-cuff 55 anteriorly against the tissues surrounding the patient's laryngeal inlet 45 in order to reinforce the seal between the inflated main-cuff and the tissues.
Additionally, the inflatable back-cushion 77 presents a more softly compliant surface to the posterior surface of the patient's throat 22. Also, the back-cushion 77 enables the main-cuff 55 to be inflated at a lower pressure, i.e., typically 60 cm H2O, as compared to the inflation pressure required of the main-cuff if the LMA-device 20 does not include a back-cushion 77. Reducing the inflation pressure of the main-cuff 55 enables a reduced wall thickness of the main-cuff.
While the invention has been described by reference to certain perferred embodiments, it should be understood that numerous changes could be made within the spirit and scope of the inventive concept described. Accordingly, it is intended that the invention not be limited to the disclosed embodiments, but that it have the full scope permitted by the language of the following claims.
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|Clasificación de EE.UU.||128/207.14, 128/207.15|
|Clasificación internacional||A61M16/04, A61M16/00|
|Clasificación cooperativa||A61M16/0488, A61M16/0409, A61M16/04, A61M16/0445, A61M2210/0656|
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Owner name: THE LARYNGEAL MASK COMPANY LTD., SEYCHELLES
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